Hospital Universitario De La Princesa
Madrid, Spain
Not recruiting
Study comparing two formulations of sacubitril and valsartan tablets in healthy volunteers to check if they work the same way in the body
Verified siteRegistered drug
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
What is this trial about?
A plain-language summary of the goals, design and what participants do
This study involves healthy volunteers and examines two formulations of a medication containing sacubitril and valsartan. The medication being tested is Entresto, which comes in tablet form and is taken by mouth. One formulation is a test version and the other is a commercial reference version that is already available on the market. Both formulations contain the same active substances in the same amounts.
The purpose of the study is to compare how the body absorbs and processes the test formulation compared to the reference formulation and to show that they work in the same way. During the study, participants will receive a single dose of the medication under fasting conditions, which means they will not have eaten before taking the tablet. The study uses a crossover design, meaning that each participant will receive both formulations at different times with a period of rest in between to allow the medication to clear from the body. Blood samples will be collected at specific times to measure the levels of the active substances in the bloodstream.
The study will measure several factors to determine if the two formulations are equivalent, including the total amount of each active substance that enters the bloodstream over time and the highest level reached in the blood. Additional measurements will look at how long it takes for the medication to reach its highest level and what percentage of the substance remains in the body after a certain period. The entire treatment period for each participant is expected to last up to two weeks.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- You must be willing to participate in the study after receiving full information about its design, objectives, and possible risks, and you must sign a written consent form showing that you agree to take part and understand that you can withdraw at any time.
- You must be between 18 and 55 years old.
- You must not have any significant physical or mental health conditions that could affect the study.
- Your medical history, which is a record of your past health problems and treatments, and your physical examination, which is when a doctor checks your body, must not show any significant abnormalities.
- Your blood tests must be normal, including tests for haematology which checks your blood cells, coagulation which measures how well your blood clots, biochemistry which checks chemicals in your blood, serology which tests for infections like Hepatitis B, Hepatitis C, and HIV, and urinalysis which examines your urine.
- Your vital signs, which include measurements like blood pressure, heart rate, breathing rate, and body temperature, and your electrocardiogram, which is a test that records the electrical activity of your heart, must not show any significant abnormalities.
Who cannot join the trial?
8 criteria
- The study does not provide specific exclusion criteria, which are conditions or factors that would prevent someone from joining the trial
- Since this study involves healthy volunteers, meaning people without any diseases, typical reasons for not being able to participate would likely include having any current illness or medical condition
- Being pregnant or breastfeeding may prevent participation, as this is common in studies testing medications
- Taking certain medications that could interfere with the study drug may not be allowed
- Having allergies to the study medication or its ingredients would prevent participation
- Having abnormal results in laboratory tests, which are blood or urine tests that check how your body is functioning, may be a reason for exclusion
- Recent participation in another clinical trial may not be permitted
- Having a history of drug or alcohol abuse may prevent you from joining
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
Tell us about your condition – we search every trial in Europe and connect you with the right site.
We usually reply within a few days
Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Verified
Trial locations
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
Not recruitingNot finding your country?
Not sure what to do next?
Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.
Investigated drugs
Sacubitril/valsartan is a combination medication used to treat heart failure. It works by helping blood vessels relax and widen, making it easier for the heart to pump blood throughout the body. This medicine combines two active ingredients that work together to reduce the strain on the heart and improve its function.
What is already known about the treatment
Sacubitril/Valsartan – This medication is a combination tablet taken by mouth that contains two active substances working together to treat heart failure. Sacubitril works by blocking an enzyme that breaks down helpful natural substances in the body, allowing blood vessels to relax and widen, while valsartan blocks receptors that cause blood vessels to narrow, and together they help reduce the strain on the heart and improve blood flow. This combination is approved and widely used in clinical practice for treating chronic heart failure, particularly in patients whose heart cannot pump blood effectively. The medication belongs to a class of drugs that affect the cardiovascular system by combining an angiotensin receptor blocker with a neprilysin inhibitor.
Investigated diseases
Healthy volunteers – This study involves healthy volunteers, which means participants who do not have any diseases or medical conditions being studied. Healthy volunteers are individuals who meet specific health criteria and do not show signs of illness. They participate in research to help evaluate medications or treatments in people without the target disease. These participants serve as a comparison group or help researchers understand how a drug works in a normal, healthy body. The study focuses on testing the bioavailability of medication formulations in individuals without medical conditions. Healthy volunteers are carefully screened to ensure they meet the health requirements for safe participation in the research.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505237-27-00Protocol codeN-SACVAL-23-278Estimated enrolment36 patientsSponsorLaboratorios Normon S.A.
sourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?